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Health product recall

Velcade (2014-08-12)

Starting date:
August 12, 2014
Posting date:
September 2, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41267

Recalled Products

Velcade

Reason

European Medicines Agency testing generated an out of specification potency result for Velcade lot DILS900.

Depth of distribution

Wholesale, Cancer Clinics, Pharmacies (Alberta, British Colombia, Manitoba, Nova Scotia, Ontario, Quebec, Saskatchewan)

Affected products

Velcade

DIN, NPN, DIN-HIM
DIN 02262452
Dosage form

Powder for solution

Strength

3.5 mg/vial

Lot or serial number

DILS900

Companies
Recalling Firm
Janssen Inc
19 Green Belt Drive
Toronto
M3C 1L9
Ontario
CANADA
Marketing Authorization Holder
Janssen Inc
19 Green Belt Drive
Toronto
M3C 1L9
Ontario
CANADA